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Efficacy of the TMPRSS2 inhibitor camostat mesilate in patients hospitalized with Covid-19-a double-blind randomized controlled trial

Gunst, Jesper D. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Staerke, Nina B. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Pahus, Marie H. (författare)
Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark
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Kristensen, Lena H. (författare)
Deptarment of Medicine, Viborg Regional Hospital, Denmark
Bodilsen, Jacob (författare)
Deptarment of Infectious Diseases, Aalborg University Hospital, Denmark
Lohse, Nicolai (författare)
Deptarment of Emergency Medicine, Copenhagen University Hospital, Hillerød, Denmark; Deptarment of Clinical Medicine, Copenhagen University, Copenhagen, Denmark
Dalgaard, Lars S. (författare)
Deptarment of Medicine, Regional Hospital West Jutland, Herning, Denmark
Brønnum, Dorthe (författare)
Centre for Clinical Research, North Denmark Regional Hospital, Hjoerring, Denmark
Fröbert, Ole, 1964- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Dept. of Cardiology
Hønge, Bo (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Internal Medicine, Randers Regional Hospital, Randers, Denmark
Johansen, Isik S. (författare)
Research Unit for Infectious Diseases, Odense University Hospital, University of Southern Denmark, Denmark
Monrad, Ida (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Erikstrup, Christian (författare)
Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Deptarment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark
Rosendal, Regitze (författare)
Deptarment of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark
Vilstrup, Emil (författare)
Deptarment of Medicine, Viborg Regional Hospital, Denmark
Mariager, Theis (författare)
Deptarment of Infectious Diseases, Aalborg University Hospital, Denmark
Bove, Dorthe G. (författare)
Deptarment of Emergency Medicine, Copenhagen University Hospital, Hillerød, Denmark
Offersen, Rasmus (författare)
Deptarment of Medicine, Regional Hospital West Jutland, Herning, Denmark
Shakar, Shakil (författare)
Deptarment of Internal Medicine, North Denmark Regional Hospital, Denmark; Deptarment of Emergency Medicine, North Denmark Regional Hospital, Denmark
Cajander, Sara, 1980- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Deptarment of Infectious Diseases
Jørgensen, Nis P. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Internal Medicine, Randers Regional Hospital, Randers, Denmark
Sritharan, Sajitha S. (författare)
Deptarment of Medicine, Viborg Regional Hospital, Denmark
Breining, Peter (författare)
Deptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark
Jespersen, Søren (författare)
Deptarment of Emergency Medicine, Copenhagen University Hospital, Hillerød, Denmark
Mortensen, Klaus L. (författare)
Deptarment of Medicine, Regional Hospital West Jutland, Herning, Denmark
Jensen, Mads L. (författare)
Deptarment of Medicine, Viborg Regional Hospital, Denmark
Kolte, Lilian (författare)
Deptarment of Lung and Infectious Diseases, Copenhagen University Hospital, Hillerød, Denmark
Frattari, Giacomo S. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Larsen, Carsten S. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Storgaard, Merete (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Nielsen, Lars P. (författare)
Deptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Biomedicine, Aarhus University, Aarhus, Denmark
Tolstrup, Martin (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark
Sædder, Eva A. (författare)
Deptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Biomedicine, Aarhus University, Aarhus, Denmark
Østergaard, Lars J. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark
Ngo, Hien T. T. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Jensen, Morten H. (författare)
Deptarment of Health Science and Technology, Aalborg University, Aalborg, Denmark; Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark
Højen, Jesper F. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark
Kjolby, Mads (författare)
Deptarment of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark; DANDRITE, Deptarment of Biomedicine, Aarhus University, Aarhus Denmark; Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark; University of Dundee, Scotland, United Kingdom
Søgaard, Ole S. (författare)
Deptarment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; Deptarment of Clinical Medicine, Aarhus University, Aarhus, Denmark
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 (creator_code:org_t)
Elsevier, 2021
2021
Engelska.
Ingår i: eClinicalMedicine. - : Elsevier. - 2589-5370. ; 35
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Background: The trans-membrane protease serine 2 (TMPRSS2) is essential for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cell entry and infection. Efficacy and safety of TMPRSS2 inhibitors in patients with coronavirus disease 2019 (Covid-19) have not been evaluated in randomized trials.Methods: We conducted an investigator-initiated, double-blind, randomized, placebo-controlled multicenter trial in patients hospitalized with confirmed SARS-CoV-2 infection from April 4, to December 31, 2020. Within 48 h of admission, participants were randomly assigned in a 2:1 ratio to receive the TMPRSS2 inhibitor camostat mesilate 200 mg three times daily for 5 days or placebo. The primary outcome was time to discharge or clinical improvement measured as ≥2 points improvement on a 7-point ordinal scale. Other outcomes included 30-day mortality, safety and change in oropharyngeal viral load. ClinicalTrials.gov Identifier: NCT04321096. EudraCT Number: 2020-001,200-42.Findings: 137 patients were assigned to receive camostat mesilate and 68 to placebo. Median time to clinical improvement was 5 days (interquartile range [IQR], 3 to 7) in the camostat group and 5 days (IQR, 2 to 10) in the placebo group (P = 0·31). The hazard ratio for 30-day mortality in the camostat compared with the placebo group was 0·82 (95% confidence interval [CI], 0·24 to 2·79; P = 0·75). The frequency of adverse events was similar in the two groups. Median change in viral load from baseline to day 5 in the camostat group was -0·22 log10 copies/mL (p <0·05) and -0·82 log10 in the placebo group (P <0·05).Interpretation: Under this protocol, camostat mesilate treatment was not associated with increased adverse events during hospitalization for Covid-19 and did not affect time to clinical improvement, progression to ICU admission or mortality.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

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